Evaluation of Success Rate of Partial Pulpotomy Versus Complete Pulpotomy in Primary Molars Using NeoPUTTY MTA

NCT06524076 | Not Yet Recruiting DMC

• 1 other identifier: 28052024
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluating the clinical and radiographic success of partial pulpotomy compared to complete pulpotomy in vital primary second molars with reversible pulpitis using NeoPUTTY™ (MTA).

Conditions

Pulp Disease, Dental

Outcome Measures

Primary Outcomes (3)

• Postoperative pain

  Postoperative pain assessment through Visual Analog Scale (the lower the value the better).

  one week postoperative

• Swelling/ Fistula

  Assessment of swelling and fistula through visual examination.

  3, 6, 9, 12 months

• Mobility

  Assesment of pathological mobility using mobility test.

  3, 6, 9, 12 months

Secondary Outcomes (1)

• Radiographic success

  0, 6, 12 months

Study Arms (2)

Partial Pulpotomy

EXPERIMENTAL

Procedure: Partial Pulpotomy

Complete pulpotomy

ACTIVE COMPARATOR

Procedure: Complete pulpotomy

Interventions

Partial Pulpotomy PROCEDURE

After removing caries high-speed handpiece with water coolant using a round diamond bur. Once there is an exposure, the bur is changed with another sterile one with which the superficially inflamed pulp tissue will be gently removed to a depth of 1-3 mm beneath the pinpoint pulp exposure that occurred at the end of caries removal. A sterile cotton pellet with saline will be placed with light pressure for 2-3 minutes to achieve hemostasis.

Partial Pulpotomy

Complete pulpotomy PROCEDURE

After removing caries with a large round bur, the access cavity will be opened. Excavation of inflamed coronal pulp tissues will be done using a sharp excavator. A sterile cotton pellet with saline will be placed with light pressure for 2-3 minutes to achieve hemostasis.

Complete pulpotomy

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients:
• Aged 4-7 years, in good general health and medically within normal.
• Teeth:
• Restorable mandibular second primary molars.
• History of reversible pulpitis.
• Preoperative radiograph:
• Absence of periapical or inter-radicular radiolucency.
• Absence of widening of periodontal ligaments (PDL) space.
• Absence of internal or external root resorption.

You may not qualify if:

• Patients:
• With systemic disorders.
• Physical or mental disabilities.
• Unable to attend follow-up visits.
• Refusal of Participation.
• Refusal to sign the informed consent.
• Teeth:
• Previously accessed teeth.
• Mobile mandibular second primary molar.
• Swelling in the vestibule or on palpation.
• Pain on percussion.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Hany M. Saber, PHD

  Faculty of Dental Medicine, Cairo University

  STUDY CHAIR

• Hanaa M. Abd El Moniem, PHD

  Faculty of Dental Medicine, Cairo University

  STUDY DIRECTOR

• Yara A. Badr, Masters

  Faculty of Dental Medicine, Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yara A. Badr, Masters

CONTACT

+201001151170; yara.badr@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal resident of Pediatric Dentistry and Public Health, Cairo University

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 29, 2024
• Study Start: September 22, 2024
• Primary Completion: December 22, 2024
• Study Completion: December 22, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08